Anthera Pharmaceuticals Inc (NASDAQ:ANTH) reported that the final subject has completed the last visit in the initial treatment phase of RESULT, which is a Phase III clinical trial of Sollpura targeting exocrine pancreatic insufficiency due to cystic fibrosis. Two successful interim futility assessments were done by the independent Data Monitoring Committee. During these reviews, no safety issues were reported, and it was suggested that the trial continue as planned.
The RESULT study registered 140 patients in age group of 7 to 58 years. Before randomization, the big percentage of subjects were on Creon while 42% of subjects were on gastric acid suppressants. Depending on the results of the RESULT trial, Sollpura has the prospect to become the preliminary oral, non-porcine PERT.
Anthera reported that top line report will be released later this quarter. Craig Thompson, the CEO and President, expressed that they are merely weeks away from launch of top line data. Now that the final subject has closed the last treatment visit in their RESULT trial, they are approaching closer to data release period. Sollpura is advancing towards potentially offering the first oral, non-porcine PERT. They expect posting the top line report once available.
Dr. Michael W. Konstan expressed that results from the previous SOLUTION trial and the solubility features of Sollpura indicate that the higher dosing given in the RESULT trial will attain non-inferiority to porcine PERTs. They intend to launch an alternative source for pancreatic enzyme replacement, and they look forward to the much awaited data. Anthera marks as a clinical-stage biopharmaceutical firm focused on advancing products to treat life-threatening and serious diseases.
In the last trading session, the stock price of Anthera declined more than 2% to close the day at $2.36. The decline came at a share volume of 10.72 million compared to average share volume of 1.93 million.
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